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Abstract
IN VITRO COMPARATIVE STUDY OF PHARMACEUTICAL QUALITY OF DIFFERENT BRANDS OF DICLOFENAC SODIUM TABLETS AND AMPULES BEFORE AND AFTER EXPIRY DATE
Ghaedaa Youssef* and Ayat Abbood
ABSTRACT
The objective of this study was to assess the pharmaceutical quality parameters of expired and unexpired diclofenac sodium coated tablets and ampules. Appearance, weight variation, hardness, content uniformity, TLC analysis, and dissolution profile were evaluated for expired and unexpired coated tablets, whereas for ampules, only appearance, content uniformity, and TLC analysis were assessed. The physical properties did not differ between expired and unexpired diclofenac sodium coated tablets and ampules. The content uniformity and TLC tests showed no degradation of diclofenac after the expiry date in both forms (tablets and ampules), as all values were within the USP limits. The dissolution profiles of expired and unexpired tablets were similar (f1 less than 15 and f2 more than 50). Diclofenac sodium preparations retained their pharmaceutical quality characteristics after the expiry date.
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